EU → North America Device Access

Achim Ruthner GmbH

DE-MF-000016101 · Germany · Hirschhorn

Achim Ruthner GmbH is registered in the European database on medical devices as a manufacturer, with 809 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa809

Among these devices, 2 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 809 declared devices.

Catalogue references include 103109306, 103409307, 200202307, 205148309, 224248307, 372600107.

European nomenclature codes declared: Y060403, Y060621, Y061209, Y06120601, Y060312, Y060308.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED809
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN809
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Achim Ruthner GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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